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Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief (PRP)

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Platelet rich plasma
Methylprednisolone
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with positive tests for rotator cuff pain
  2. Patients with positive radiological (US or MRI) findings of partial rotator cuff tear

Exclusion Criteria:

  1. Patient refusal
  2. Age less than 20 years.
  3. Infection at injection site.
  4. Prior surgery on the shoulder joint area.
  5. Presence of other associated pathology in the shoulder joint
  6. Patients using antiplatelet drugs (aspirin).
  7. Contraindications to the use of platelet concentrate
  8. Contraindications to the steroids injection

Sites / Locations

  • Facility of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Platelet rich plasma group

Methylprednisolone group

Arm Description

participants will receive Ultrasound guided subacromial injection of 3 ml platelet rich plasma+0.5 ml of PRP activator (10% calcium gluconate)+ 1ml 0.5%bupivacaine.

participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline.

Outcomes

Primary Outcome Measures

Shoulder pain assesment
The pain will be assessed using visual analogue scale( score range=0-10,less than 4,4-6 and more than 6 for mild, moderate and severe pain respectively)

Secondary Outcome Measures

Assesment of rotator cuff tendon healing
assesment healing process of tendon using ultrasound technique
Assesment the failure rate after shoulder joint injection
failure of relief the symptoms after shoulder joint injection will be recorded
The reinjection rate recording
the incidence of reinjection the shoulder joint due to inadequate pain relief will be recorded
Assesment the rate of tear recurrence after shoulder joint injection
The rate of tear recurrence after 4 months of injection will be assessed using MRI or US
Simple shoulder assessment test
Functional assessment of shoulder joint will be done using simple sholder assessment test 0= maximal disability 20% -40% = crippled 40% -60% = severe disability 60% -80% = moderate disability 100% = no disability

Full Information

First Posted
July 19, 2021
Last Updated
April 2, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05317624
Brief Title
Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief
Acronym
PRP
Official Title
Evaluation of Ultrasound Guided Platelet Rich Plasma Injection Versus Steroids Injection for Pain Relief in Cases of Partial Rotator Cuff Tears
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Comparison between effects of ultrasound guided platelet rich plasma injection versus steroids injection for pain relief in cases of partial rotator cuff tears
Detailed Description
The effect of injection of platelet rich plasma will be compared with effects of steroids injection according to pain relief effects,, Side effects ,, healing ability ,, recurrence in both groups. 30 patient in each group will be included

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
2 groups will be included
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet rich plasma group
Arm Type
Experimental
Arm Description
participants will receive Ultrasound guided subacromial injection of 3 ml platelet rich plasma+0.5 ml of PRP activator (10% calcium gluconate)+ 1ml 0.5%bupivacaine.
Arm Title
Methylprednisolone group
Arm Type
Experimental
Arm Description
participants will receive Ultrasound guided subacromial injection of 1 ml methylprednisolone+ 1ml 0.5%bupivacaine + 2.5 ml normal saline.
Intervention Type
Combination Product
Intervention Name(s)
Platelet rich plasma
Other Intervention Name(s)
PRP group
Intervention Description
platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine
Intervention Type
Combination Product
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
steroids group
Intervention Description
1ml methyl prednisolone 40mg\ml mixed with normal saline and bupivacaine
Primary Outcome Measure Information:
Title
Shoulder pain assesment
Description
The pain will be assessed using visual analogue scale( score range=0-10,less than 4,4-6 and more than 6 for mild, moderate and severe pain respectively)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Assesment of rotator cuff tendon healing
Description
assesment healing process of tendon using ultrasound technique
Time Frame
4 months
Title
Assesment the failure rate after shoulder joint injection
Description
failure of relief the symptoms after shoulder joint injection will be recorded
Time Frame
4 months
Title
The reinjection rate recording
Description
the incidence of reinjection the shoulder joint due to inadequate pain relief will be recorded
Time Frame
4 months
Title
Assesment the rate of tear recurrence after shoulder joint injection
Description
The rate of tear recurrence after 4 months of injection will be assessed using MRI or US
Time Frame
4 months
Title
Simple shoulder assessment test
Description
Functional assessment of shoulder joint will be done using simple sholder assessment test 0= maximal disability 20% -40% = crippled 40% -60% = severe disability 60% -80% = moderate disability 100% = no disability
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Measurement plasma C-Reactive Protein level
Description
The plasma C- Reactive Protein level will be measured prior to injection and 4 months later on after the procedure
Time Frame
4 months
Title
Measurement the fasting blood glucose level
Description
The fasting blood glucose level will be measure prior to and one week later after injection
Time Frame
one week
Title
Assesment the complications after shoulder joint injection
Description
Complications that might occur after shoulder joint injection such as infection, elevated blood sugar, allergy, nerve injury, nausea and vomiting will be recorded
Time Frame
4 months
Title
Measurement the serum cortisol level
Description
Early morning(8 am serum cortisol level) will be measured before the injection and one week later after injection
Time Frame
one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with positive tests for rotator cuff pain Patients with positive radiological (US or MRI) findings of partial rotator cuff tear Exclusion Criteria: Patient refusal Age less than 20 years. Infection at injection site. Prior surgery on the shoulder joint area. Presence of other associated pathology in the shoulder joint Patients using antiplatelet drugs (aspirin). Contraindications to the use of platelet concentrate Contraindications to the steroids injection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorreya Fikry
Organizational Affiliation
AlexandriaUniversity
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek Sarhan
Organizational Affiliation
AlexandriaUniversity
Official's Role
Study Director
Facility Information:
Facility Name
Facility of medicine
City
Alexandria
ZIP/Postal Code
21519
Country
Egypt

12. IPD Sharing Statement

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Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief

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